Pharmacovigilance assessments: challenges and solutions for pharmacovigilance assessors

Date: 11/11/2019 to 12/11/2019
Location: European Medicines Agency, Amsterdam, The Netherlands

This training is organised for pharmacovigilance assessors in the European Union and the European Economic Area and delegates from the Pharmacovigilance Risk Assessment Committee (PRAC) who assess pharmacovigilance procedures at their national competent authorities.

It covers:

  • pharmacovigilance assessments and its challenges and solutions;
  • the safe use of medicines during pregnancy and lactation;
  • ways of gathering data via post-authorisation safety studies;
  • assessing advanced therapies;
  • assessing drug-induced liver injury.  

Participation in this training is also possible via webinar.

A limited number of places is available for non-EU regulators that have confidentiality agreements in place with EMA, on a first come, first served basis. Please note that EMA does not offer financial support for the participation of non-EU regulators in this event. 

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